BioGaia Pharma is a subsidiary of BioGaia. This means we can benefit from 30 years’ experience of research within the microbiota when we develop the biological product category which the FDA in the USA calls Live Biotherapeutic Products, which refers to pharmaceutical products that stem from the microbiota.
Potential product candidates are selected early in the discovery or pre-clinical phase and the requirement is that they have a potential effect in well-defined medical indications. Most candidates come from BioGaia’s own research and bank of probiotic strains or are licensed in. Through BioGaia Pharma’s established network of doctors and researchers, the products are developed up to and including the early clinical development phase. Subsequently, the project can be licensed out for further development by or in partnership with pharmaceutical or similar companies.
During 2020 we worked with two projects, both with candidates in a development phase. One product candidate has potential for use in mild to moderate ulcerous colic, which is one of the diseases included under the designation inflammatory bowel disease (IBD). A lot of research is taking place into IBD and even though the cause has not yet been fully identified, there are many indications that the interaction between the microbiota, inflammation and the so-called ‘leaky gut’ are highly significant.
The second product candidate is intended to be used in specific motility disorders in the intestine that cause constipation and where today’s solutions are not optimal.
We have mainly focused on developing study products for these two product candidates. In parallel we have also completed trial applications for two clinical studies. Study centres have been chosen and contracted and the studies are planned to start in 2021.
2021 will be an exciting year in which I look forward to being able to provide additional information about both the product candidates and the clinical studies.